First fully integrated
eTMF / eISF
Designed by Kestrel and BioStat® specifically for the eClinical market, this novel solution brings together electronic Trial Master Files (eTMF) with electronic Investigator Site Files (eISF), integrating their features into a single system.
Files are synchronized constantly over the cloud when connected to the Internet, while at the same time being accessible through offline copies stored at the computer’s hard drive. This way, files are kept safe during both transfer and storage.
The set-up of SMART.KESTREL allows for remote control of eISF content and allows for real-time updates between the Sponsor and site files. The actions feature provides an option to generate customizable reports and set-up quality checks according to Client's procedures.
SMART.KESTREL contains all components, controls and policies for eTMF and eISF that are required according to: US FDA CFR 21 part 11, EU Annex 11 and Good Clinical Practice. The application has native support for health authority inspections, proving its ability to ensure records retention.
TMF Reference model version 3.0 was followed in order to provide standardized eTMF and eISF structures.
With the SMART.KESTREL the costs related to printing, shipping, storage and on-site verification get minimised. In addition this application can include other features: Essential Documents review and distribution of safety reports.
During the software’s setup, the Client can decide on the structure of the files, their naming and access types. This system allows flexibility even in the highest level of detail (ultimate subfolder - individual user)
By using SMART.KESTREL majority of the document flow between Sponsor and Site is based on the upload and send features of the program, reducing the need to verify paper files at sites.
SMART.KESTREL is an easy and handy system to use. Both navigation and organization of the files are intuitive and much more convenient than paper-based standards.
When you need to know
everything about your project
Our CTMS is available online and offline with an integrated background synchronization system. The application allows you to easily access and use the most recent data, and to write visit reports at any time, any place. Our document creation engine makes it simple to prepare reports and dashboards using your patients' data imported from the eCRF, write and finalise visit reports, and manage grant payments as well.
A modern data collection system for clinical and observational studies.
BioStat® offers a unique, modular eCRF.biz.pl™ system, made to cater to the scientific needs of the pharmaceutical sector. eCRF.biz.pl™ allows you to completely eliminate paper case report forms, enabling you to move your data into an electrical form safely and securely.
- Compliance with FDA Guidelines (Title 21 CFR Part 11)
- Statistics for collected data and research process
- Ability to print AE / SAE (e.g. CIOMS) and CRF forms
- Internal messaging system
- Double Data Entry
- Exports the data to popular formats
- Limited access – patients and researchers get access to assigned centers only
- Compliance with standard operating procedures (SOPs) and Good Clinical Practice (GCP)
eCRF.biz.pl™ is used by a wide variety of specialists and scientific centers, all of which help improve the software by asking questions and providing suggestions. Thanks to our users we can constantly work on designing and implementing solutions that are perfect for specific purposes.
Any questions? We're happy to help!
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